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FDA 510(k)

VAX-D GENESIS G2 SYSTEM

K-Number: K071347 · 2007-10-05

ApplicantVax-D Medical Technologies, LLC
Decision Date2007-10-05
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VAX-D GENESIS G2 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vax-D Medical Technologies, LLC. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K071347. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAX-D GENESIS G2 SYSTEM?

VAX-D GENESIS G2 SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Vax-D Medical Technologies, LLC. The 510(k) number is K071347.

When did VAX-D GENESIS G2 SYSTEM receive FDA 510(k) clearance?

VAX-D GENESIS G2 SYSTEM received FDA 510(k) clearance on 2007-10-05, under 510(k) number K071347.

Who is the listed applicant for VAX-D GENESIS G2 SYSTEM?

The FDA 510(k) record lists Vax-D Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAX-D GENESIS G2 SYSTEM?

The FDA product code for VAX-D GENESIS G2 SYSTEM is ITH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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